search
Back to results

VISIODOL: Validation of the VISIODOL® Scale (VISIODOL)

Primary Purpose

Visual Deficiency, Congenital Blindness, Acquired Blindness

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VISIODOL® (Diagnostic tool)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Visual Deficiency focused on measuring Blinded population, Pain evaluation, Diagnostic tool

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • Subjects aged over 18 / under 60
  • Male or female
  • Subjects fasting from coffee, tea, Coca-Cola and others stimulants
  • Sufficient understanding and cooperation to comply with the study requirements
  • Agreed to provide written consent
  • Affiliated to the social security
  • Subjects with visual impairment (congenital or acquired)
  • Subjects with no visual impairment (healthy group)

Exclusion Criteria:

  • Subjects under 18 years old
  • Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)

Sites / Locations

  • Chu Clermont Ferrand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Healthy volunteer group

Subjects with acquired visual impairment

Subjects with congenital visual impairment

Arm Description

male or female healthy volunteers

visual acquired disability

Visual congenital disability

Outcomes

Primary Outcome Measures

Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
Determination of the correlation coefficient between NS and VISIODOL® scale for different pain temperatures by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.

Secondary Outcome Measures

Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests .
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by electronic Von Frey®. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.
Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.
Determination of the correlation coefficient between NS and VISIODOL® scale for tolerance threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Comparison of pain perception between the 3 groups
comparison of NS and VISIODOL® scoring for pain threshold by hot thermal tests (Pathway Medoc®).
Evaluation of the ergonomic qualities of the scale
ergonomic survey : Different ergonomic parameters such as length, width and granulometry will be evaluated using a questionnaire.
Evaluation of satisfaction of the use of the scale
satisfaction survey : The satisfaction of the participants in the study will be collected by means of a questionnaire.
Evaluation of anxiety
Hospital and Anxiety Depression Scale (HAD) : The Hospital Anxiety and Depression scale is a self-administered questionnaire in 14 items completed by the patient. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Global score ranges from 0 to 42.

Full Information

First Posted
April 29, 2019
Last Updated
March 9, 2023
Sponsor
University Hospital, Clermont-Ferrand
search

1. Study Identification

Unique Protocol Identification Number
NCT03968991
Brief Title
VISIODOL: Validation of the VISIODOL® Scale
Acronym
VISIODOL
Official Title
VISIODOL: Validation of the VISIODOL® Scale for Screening of Pain in People With Visual Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
low recruits
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
December 28, 2020 (Actual)
Study Completion Date
December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to validate the VISIODOL® scale for screening of pain in people with visual impairment.
Detailed Description
The VISIODOL® monocentric study conducted at Clermont-Ferrand University Hospital is a cross-disciplinary diagnostic tool validation performed in patients with acquired or congenital visual impairment and healthy sighted volunteers. Different evaluations by thermal (Pathway Médoc®) and mechanical (electronic Von Frey®) tests will allow to compare the new VISIODOL® scale with the numerical scale, which is a commonly used tool. The ergonomic quality, the satisfaction of use and the quality of life, stress, anxiety and catastrophism of the patients will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Deficiency, Congenital Blindness, Acquired Blindness
Keywords
Blinded population, Pain evaluation, Diagnostic tool

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteer group
Arm Type
Active Comparator
Arm Description
male or female healthy volunteers
Arm Title
Subjects with acquired visual impairment
Arm Type
Experimental
Arm Description
visual acquired disability
Arm Title
Subjects with congenital visual impairment
Arm Type
Experimental
Arm Description
Visual congenital disability
Intervention Type
Diagnostic Test
Intervention Name(s)
VISIODOL® (Diagnostic tool)
Intervention Description
Tool for assessing pain in the blind subject (with congenital or acquired deficiency)
Primary Outcome Measure Information:
Title
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
Description
Determination of the correlation coefficient between NS and VISIODOL® scale for different pain temperatures by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Time Frame
Day 0 + 2 hours
Secondary Outcome Measure Information:
Title
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
Description
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by hot thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Time Frame
Day 0 + 2 hours
Title
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests .
Description
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Time Frame
Day 0 + 2 hours
Title
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using thermal tests.
Description
Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by cold thermal tests. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Time Frame
Day 0 + 2 hours
Title
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.
Description
Determination of the correlation coefficient between NS and VISIODOL® scale for sensitive threshold by electronic Von Frey®. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Time Frame
Day 0 + 2 hours
Title
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.
Description
Determination of the correlation coefficient between NS and VISIODOL® scale for pain threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Time Frame
Day 0 + 2 hours
Title
Validation of the VISIODOL® scale in screening of pain in people with visual impairment using the correlation coefficient between the intensities measured with the Numerical Scale (NS) and the VISIODOL® scale obtained by using mechanical tests.
Description
Determination of the correlation coefficient between NS and VISIODOL® scale for tolerance threshold by electronic Von Frey. The rating of the NS and VISIODOL® scales can range from 0 to 10.
Time Frame
Day 0 + 2 hours
Title
Comparison of pain perception between the 3 groups
Description
comparison of NS and VISIODOL® scoring for pain threshold by hot thermal tests (Pathway Medoc®).
Time Frame
Day 0 + 1 hour
Title
Evaluation of the ergonomic qualities of the scale
Description
ergonomic survey : Different ergonomic parameters such as length, width and granulometry will be evaluated using a questionnaire.
Time Frame
Day 0 + 1 hour
Title
Evaluation of satisfaction of the use of the scale
Description
satisfaction survey : The satisfaction of the participants in the study will be collected by means of a questionnaire.
Time Frame
Day 0 + 1 hour
Title
Evaluation of anxiety
Description
Hospital and Anxiety Depression Scale (HAD) : The Hospital Anxiety and Depression scale is a self-administered questionnaire in 14 items completed by the patient. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Global score ranges from 0 to 42.
Time Frame
Day 0 + 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Subjects aged over 18 / under 60 Male or female Subjects fasting from coffee, tea, Coca-Cola and others stimulants Sufficient understanding and cooperation to comply with the study requirements Agreed to provide written consent Affiliated to the social security Subjects with visual impairment (congenital or acquired) Subjects with no visual impairment (healthy group) Exclusion Criteria: Subjects under 18 years old Administrative and legal criteria (tutorship, curatorship, without social security, in exclusion period of another study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle Pickering
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Learn more about this trial

VISIODOL: Validation of the VISIODOL® Scale

We'll reach out to this number within 24 hrs